The design and evaluation of hybrid controlled trials that leverage external data and randomization

HIGHLIGHTS

• who: Steffen Ventz from the In silico trials in GBM We used five GBM5, datasets (see Methods and Supplementary Table, ) to compare HT, ECT, and RCT designsWe considered a study with a sample size of , patients, as the primary endpoint, and an IA after , enrollments. The initial randomization ratio r1, C:r1, E was, :, for both the HT and RCT designs. For the HT design, the randomization ratio during the second stage remained, :, or was updated to r2, C:r2, E (we considered, :, and, :1). We generated in silico trials resampling from GBM datasets (Chinot et_al16, Dana . . .
  

   

  

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